Premature infants are unable to coordinate sucking,swallowing and breathing, therefore require gavage feeding.intermittent gavage can be given by gravity or push.gravity feed is defined as an intermittent when milk is poured into a syringe(using the syringe as a funnel) that is attached to an intra-gastric feeding tubeand milk is allowed to drip into the infants stomach by gravity and adjutant height.push is administered using a syringe to push milk into the infants stomach.objective this study is :comparsion early outcomes intermittent gavage in preterm infants.study infants are inrolled with sixth and seventh day of birth,infants have the same nasal tube feeding and received human milk.infant position before and half hour after gavage is supine.outcomes in this study consist of :physiological index(heart rate,breathing,O2sat) before ,execution time and 10 minute after gavage in one day( 8-12 times) .feeding tolerance is assessed by:gastric residual volume(GVR,determined by aspiration of gastric contents from the indwelling nasal tube feeding every 2-3hour in all infants),emesis,abdominal distention and necrotizing enterocolits for two days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201408205168N7
Registration date:2015-03-15, 1393/12/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-03-15, 1393/12/24
Registrant information
Name
Maliheh Assadollahi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
assadollahim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Science
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2015-06-20, 1394/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparsion early outcomes intermittent gavage in preterm infants :randomized clinical trial
Public title
The comparsion early outcomes intermittent gavage in preterm infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:1- gastational age(28-34)week and AGA 2-NG tub feeding in sixth and seventh day 3-weight<2500gr 4- absence of major congenital malformation and heart disease 5- did not have any apnoea and shock in 24 hour 6-Disruption ventilation,NCPAP,HFNC 7-parents satisfaction 8-high apgar(fifth minuts apgar was more seven) 9- without umbilical vain catheter.
Exclusion criteria:1- affection to PDA to need medical 2-NEC in execution time 3-sepsis 4-IVH(2 degree and more) 5-inexistence stability vital sign 6-lack of parents satisfaction 7-hypotention need to vasopresor
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Central Building of Tabriz University of Medical Sciences,Golgasht Avenue, azadi street,Tabriz
City
Tabriz
Postal code
33359680
Approval date
2015-02-23, 1393/12/04
Ethics committee reference number
93180
Health conditions studied
1
Description of health condition studied
Infant gavage outcome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Physiological index(heart rate,breathing and O2 saturation
Timepoint
Before ,execution time and 10 minuts after gavage in one day
Method of measurement
Before,execution time and 10 minuts after gavage written in check list
Secondary outcomes
1
Description
Gastric residual volume is secondary outcom,emesis,abdominal distention and necrotizing enterocolits for two days checking instance side effect
Timepoint
Before feeding gavage every 2-3 hours in two days gastric residual checking and side effect recording in check list
Method of measurement
Aspiration of gastric contents from the indwelling nasal tube feeding every 2-3 hours and emesis with observation and abdominal distention and NEC with physician diagnosis
Intervention groups
1
Description
Infant gavage with gravity in intervention group
Category
Prevention
2
Description
Infant gavage with administered using a syringe in control group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Educational Center Affiliated
Full name of responsible person
Samaneh Sadat Sajassi
Street address
South artesh Avenue-across from Baghshomal
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Malihe Assadollahi
Street address
Department of Pediatrics, School of nursing and Midwifery, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Mahnaz Jabraeili
Position
MSc in pediatric Nursing
Other areas of specialty/work
Street address
South Shariety St. Faculty of Nursing & Midwifery,Tabriz
City
Tabriz
Postal code
347-51745
Phone
+98 41 3477 0648
Fax
Email
jabraeilim@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alzahra hospital
Full name of responsible person
Dr Mohamad Bagher Hosseini
Position
Neonatalogist
Other areas of specialty/work
Street address
South artesh Avenue-across from Baghshomal
City
Tabriz
Postal code
5138665793
Phone
+98 413553916163
Fax
+98 41 3556 6449
Email
hosseini.neo@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Malihe Assadollahi
Position
MSc in pediatric Nursing
Other areas of specialty/work
Street address
Department of Pediatrics, School of nursing and Midwifery, Tabriz
City
Tabriz
Postal code
347-51745
Phone
+98 41 3477 0648
Fax
+98 41 1479 6969
Email
assadollahim@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)